Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-01 @ 6:41 AM
Study NCT ID:
NCT06488066
Status:
WITHDRAWN
Last Update Posted:
2024-07-05
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Patients Implanted With the RxSight Light Adjustable Lens (LAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D019591', 'term': 'Pseudophakia'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Never completed this study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Manifest refraction', 'timeFrame': 'Pre operatively and immediately post operatively', 'description': 'A qualified ophthalmologist, optometrist, or a trained ophthalmic technician should obtain the refraction, in 0.25D steps, in a calibrated refraction lane. If the subject has a current pair of glasses for distance vision, they can be measured with a lensometer, and these measurements are used as the beginning approximate refraction'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cataract', 'Pseudophakia']}, 'descriptionModule': {'briefSummary': 'The objective of this investigator initiated study (IIT-002) is to collect data on commercial patients implanted with the RxSight Light Adjustable Lens (LAL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 50 commercial patients who have been implanted with the LAL and who have completed Light Delivery Device (LDD) light treatments.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign a written Informed Consent Document\n* Implanted commercially with the LAL and completed LDD light treatments\n\nExclusion Criteria:\n\n* Previous corneal or intraocular surgery other than removal of cataract and implantation of the LAL'}, 'identificationModule': {'nctId': 'NCT06488066', 'briefTitle': 'Clinical Outcomes of Patients Implanted With the RxSight Light Adjustable Lens (LAL)', 'organization': {'class': 'OTHER', 'fullName': 'Vance Thompson Vision'}, 'officialTitle': 'Clinical Outcomes of Patients Implanted With the RxSight Light Adjustable Lens (LAL)', 'orgStudyIdInfo': {'id': 'IIT-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Collection of clinical data from groups of patients already implanted with the light adjustable lens (LAL) and have completed light treatments.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vance Thompson Vision', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}